CPS Direct Universal Slittable Outer Guide Catheter - Catheter, cardiac, ventricular

Main information

  • Trade name:
  • CPS Direct Universal Slittable Outer Guide Catheter - Catheter, cardiac, ventricular
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • CPS Direct Universal Slittable Outer Guide Catheter - Catheter, cardiac, ventricular
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Included
  • Authorization number:
  • 219168
  • Last update:
  • 03-06-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219168

St Jude Medical Australia Pty Ltd - CPS Direct Universal Slittable Outer Guide Catheter - Catheter, cardiac,

ventricular

ARTG entry for

Medical Device Included Class III

Sponsor

St Jude Medical Australia Pty Ltd

Postal Address

17 Orion Road,LANE COVE, NSW, 2066

Australia

ARTG Start Date

13/01/2014

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

St Jude Medical Cardiac Rhythm Management

Division USA

15900 Valley View Court

Sylmar, California, 91342

United States Of America

Products

1. CPS Direct Universal Slittable Outer Guide Catheter - Catheter, cardiac, ventricular

Product Type

Single Device Product

Effective date

13/01/2014

GMDN

17613 Catheter, cardiac, ventricular

Functional description

The catheter is used to facilitate left heart lead delivery during CRT procedures. The catheter provides

access to the coronary venous system and act as a conduit for contrast medium, implantable coronary

leads or other devices. The package includes 1 outer catheter, 1 dilator and 2 valve bypass tools.

Intended purpose

The CPS Direct Universal slittable outer guide catheter is designed for intracardiac access of the venous

system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and

St Jude Medical devices (including implantable left heart leads and delivery tools), and support of fluids

where minimising blood loss is essential. In addition, the catheters can work with inner catheters as a

system.

Variant information

Shape (of tip) Extra Wide

Shape (of tip) Straight

Shape (of tip) Wide

Shape (of tip) 115°

Length (cm) 47-54

Shape (of tip) Right Side

Shape (of tip) 135°

Specific Conditions

No Specific Conditions included on Record

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Public Summary

Page 1 of

Produced at 10.11.2017 at 08:17:02 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information